Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

NCT04058990 | Active Not Recruiting Results FDA Device

• 1 other identifier: S2313
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 14

Brief Summary

A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)

  TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

  6 months post procedure

Other Outcomes (1)

• Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)

  6 months post procedure

Study Arms (2)

Agent Paclitaxel-Coated PTCA Balloon Catheter

EXPERIMENTAL

Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)

Device: Device: Paclitaxel-Coated PTCA Balloon Catheter

SeQuent Please Drug Eluting Balloon Catheter

ACTIVE COMPARATOR

Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)

Device: SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel

Interventions

SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel DEVICE

Percutaneous Transluminal Coronary Angioplasty

SeQuent Please Drug Eluting Balloon Catheter

Device: Paclitaxel-Coated PTCA Balloon Catheter DEVICE

Percutaneous Transluminal Coronary Angioplasty

Agent Paclitaxel-Coated PTCA Balloon Catheter

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 20 years of age.
• Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
• Subject is eligible for percutaneous coronary intervention (PCI).
• Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet.
• ≥90% diameter stenosis.
• Stenosis that is considered a cause of stable effort angina (Only when it's without confirmation of significant stenosis).
• Stenosis that is confirmed a cause of functional ischemia with any test.
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG).
• Subject is willing to comply with all protocol-required follow-up evaluation.
• Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy.
• The target lesion meets all following criteria.
• Target lesion length must measure (by visual estimate) ≤28 mm.
• Target lesion must be a visually estimated reference vessel diameter (RVD) ≥2.00mm and \<3.00 mm (This applys for SV trial. For ISR substudy: RVD ≥2.00mm and ≤4.00 mm.).
• Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis ≥75% and \<100% (This applys for SV trial. For ISR substudy: Target lesion for ISR must be in-stent restenosis of a previously-treated lesion located in a native coronary artery with visually estimated stenosis ≥75% and \<100%.).
• Coronary anatomy is likely to allow delivery of an investigational device to the lesions.

You may not qualify if:

• Subject has had an acute myocardial infarction within 72 hours prior to the index procedure.
• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina.
• Subject has severe left ventricular dysfunction with ejection fraction \<30%.
• Subject has received an organ transplant or is on a waiting list for an organ transplant.
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
• Subject has renal failure with a serum creatinine of \> 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy.
• Subjects has one of the following.
• Not expected to live for the duration of the study (1 year) by investigator's discretion due to other serious medical illness.
• Current problems with substance abuse.
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• Planned PCI (including staged procedures) or CABG after the index procedure.
• Subject previously treated at any time with intravascular brachytherapy.
• Subject has a known allergy to contrast and/or the investigational device or protocol-required concomitant medications, iopromide, raw materials of Agent DCB and SeQuent Please DCB, P2Y12 inhibitor or aspirin).
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
• Subject has a white blood cell (WBC) count \< 3,000 cells/mm3.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (14)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

Location

Japan Labour Health and Welfare Organization Kanto Rosai Hospital

Kawasaki, Kanagawa, 211-8510, Japan

Location

Shonan Kamakura General Hospital

Ōfuna, Kanagawa, 247-8533, Japan

Location

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, 230-8765, Japan

Location

Kyoto-Katsura Hospital

Kyoto, Kyoto, 615-8256, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, 880-0834, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Kita, Osaka, 530-0012, Japan

Location

Sakurabashi Watanabe Advanced Healthcare Hospital

Osaka, Osaka, 530-0001, Japan

Location

Toho University Ohashi Medical Center

Meguro City, Tokyo, 153-8515, Japan

Location

Showa Medical University Hospital

Shinagawa-Ku, Tokyo, 142-8666, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

Teikyo University Hospital

tabashi City, Tokyo, 173-8606, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

\[Not Specified\]

Results Point of Contact

• Title: Sachiyo Sato/Clinical Project Manager
• Organization: Boston Scientific Japan K.K.

Sachiyo.Sato@bsci.com

+81-3-6853-7500

Study Officials

• Masato Nakamura, MD

  Toho University Ohashi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: SV study: A prospective, multicenter, 2:1 randomized, controlled, single-blind, non-inferiority trial.150 subjects are expected to be enrolled to support a 2:1 randomization. (Investigational test device: Agent DCB, N=100 subjects or Control device: SeQuent Please DCB, N=50 subjects) ISR substudy: A prospective, multicenter, single-arm, open-label trial. 30 subjects are expected to be enrolled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 16, 2019
• Study Start: December 12, 2019
• Primary Completion: December 22, 2021
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 11, 2026
• Results First Posted: December 23, 2022

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (14)